Flavored colonic cleansing system

ABSTRACT

A kit for colonic cleansing includes a phosphate salt laxative, a flavorant, and an oral rehydration mixture. The flavorant includes aspartame and a citrate, and the oral rehydration mixture includes sodium and a glucose containing saccharide. The kit may be used for a colonic cleansing procedure by combining the phosphate salt laxative and the flavorant to provide a flavored laxative liquid, orally administering to a subject the flavored laxative liquid, and orally administering to the subject an oral rehydration liquid.

REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/778,744 entitled “Flavored Colonic Cleansing System” filed Mar. 3,2006, which is incorporated by reference in its entirety.

BACKGROUND

Colonoscopy screening coupled with polyp removal (polypectomy)significantly reduces the incidence of colorectal carcinoma. Prior tocolonoscopy, including virtual colonoscopy procedures, the colon must becleansed so the surgeon may see any polyps that exist on the interiorwall of the colon. The colon also must be cleansed before radiologicalor surgical procedures involving the colon. This cleansing generallyentails the drinking of one or more laxative mixtures.

Aqueous mixtures of sodium phosphate salts (monobasic and dibasic sodiumphosphate), such as FLEET® PHOSPHO-SODA®, are very effective orallaxatives and are extensively used prior to colonoscopy, radiologicalprocedures, and surgery. For pre-colonoscopy use, a split regimen isoften preferred that includes one 45 mL dose given the evening beforecolonoscopy and a second 45 mL dose given at least three hours prior tothe procedure on the following morning. In order to maintain adequatehydration a large amount of liquids, 3 to 4 liters (L) for example,should be consumed in addition to phosphate salt laxative. Theseadditional liquids may include oral rehydration liquid, which includessodium and a glucose containing saccharide. U.S. Patent ApplicationPublication No. 2004/0192614 A1 discloses that oral rehydration liquids,in addition to attenuating hypovolemia associated with laxativeingestion, may also result in superior colonic cleansing.

Unfortunately, of the 147,500 new cases of colorectal carcinomadiagnosed in 2003, the American Cancer Society estimates that only 37%of these cases were diagnosed early enough for treatment to offer thebest possible prognosis. In addition, colonoscopy screening should berepeated more frequently for subjects who have previously undergone apolypectomy due to their increased risk of recurrent polyp formation.However, in a follow-up phase of the National Polyp Study, at least 20%of subjects who had previously undergone polypectomies failed to returnfor their follow-up screening. In a more recent study, where 8,865subjects who had previously undergone a polypectomy underwent a secondcolonoscopy screening, 2,704 (30.5%) were diagnosed with recurrentpolyps. A statistical analysis based on the data from this reportprojected that 50% of subjects will have recurrent polyps within 7.6years. Despite this level of risk, many subjects do not undergoadditional screening.

One of the main reasons subjects cite for avoiding colonoscopyre-screening is the unpleasant taste of these phosphate based laxativemixtures. Depending on the study, from 15 to 51% of the subjects reportdiscomfort in the form of nausea and vomiting. The extremely salty tasteof the laxative mixture is believed to be the cause of this discomfort.Frequently, subjects cannot tolerate the ingestion of the completeinitial dose of the preparation, which often prevents them fromconsuming more than a small portion of the second dose.

SUMMARY

In one aspect, the invention provides a kit for colonic cleansingincluding a phosphate salt laxative; a flavorant, including aspartameand a citrate; and an oral rehydration mixture, including sodium and aglucose containing saccharide.

In another aspect, the invention provides a kit for colonic cleansingincluding at least two bottles, each containing from 10 to 75 mL aphosphate salt laxative including water, from 0.05 to 1.5 gram/mL ofmonobasic sodium phosphate, and from 0.02 to 0.6 gram/mL of dibasicsodium phosphate; at least two packets, each containing from 1 to 10grams of a powdered flavorant including aspartame and a citrate; and atleast one packet containing from 200 to 400 grams of a powdered oralrehydration mixture, the oral rehydration mixture including sodium, anda glucose containing saccharide.

These aspects may include a method for colonic cleansing using this kit,including combining the contents of at least one of the bottles of thephosphate salt laxative with at least one of the packets of theflavorant, to provide a first flavored laxative liquid; orallyadministering the first flavored laxative liquid; combining a portion ofthe oral rehydration mixture with water to provide a first oralrehydration liquid; orally administering the first oral rehydrationliquid; combining the contents of at least one of the bottles of thephosphate salt laxative with at least one of the packets of theflavorant, to provide a second flavored laxative liquid; orallyadministering the second flavored laxative liquid; combining a portionof the oral rehydration mixture with water to provide a second oralrehydration liquid; and orally administering the second oral rehydrationliquid.

In yet another aspect, the invention provides a method for coloniccleansing including combining a phosphate salt laxative and a flavorantto provide a flavored laxative liquid, orally administering to a subjectthe flavored laxative liquid, and orally administering to the subject anoral rehydration liquid. The flavorant includes aspartame and a citrate,and the oral rehydration liquid including sodium and a glucosecontaining saccharide.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention can be better understood with reference to the followingdrawings and description. The components in the figures are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the invention.

FIG. 1 is a cut-away representation of a colonic cleansing kit.

FIG. 2 is a representation of individual components that may be found ina colonic cleansing kit.

FIG. 3 is a representation of individual components that may be found ina colonic cleansing kit.

FIG. 4 is a representation of a colonic cleansing kit.

FIG. 5A is a top view representation of an open exterior package, FIG.5B is a side view representation of an open exterior package, and FIG.5C is a front view representation of a closed exterior package.

DETAILED DESCRIPTION

The present invention makes use of the discovery that adding aflavorant, which includes aspartame and a citrate, to a phosphate saltlaxative may significantly increase the palatability of the laxative,and that administration of an oral rehydration liquid as a part of acolonic cleansing procedure with this laxative may result in improvedrehydration and colonic cleansing. A better tasting pre-colonoscopylaxative may increase subject compliance with re-screening appointments.This increased compliance, combined with the improved colonic cleansingthat may be achieved with an oral rehydration mixture, may reduce theneed for repeat procedures attributable to inadequate colon cleansing.

FIG. 1 represents a kit 100 for colonic cleansing including a phosphatesalt laxative 110, a flavorant 120 and an oral rehydration mixture 130.The kit may also include optional exterior package 140. The kit mayoptionally include one or more additional items, such as a container forcombining ingredients, anorectal wipes, and instructions.

The phosphate salt laxative 110 typically includes monobasic sodiumphosphate (sodium dihydrogen phosphate, monohydrate —NaH₂—PO₄.H₂O) anddibasic sodium phosphate (disodium hydrogen phosphate,heptahydrate—Na₂—HPO₄.7H₂O) in water. Phosphate salt laxatives typicallyhave a pH from about 4.4 to about 5.2 and may be produced in multipleways, such as by combining phosphoric acid with dibasic sodium phosphateor with caustic soda. Laxatives of this type are very stable, thushaving a long shelf-life, and are considered to work in a mild and veryefficient manner. An example of a phosphate salt laxative is the FLEET®PHOSPHO-SODA® liquid, available from C.B. Fleet, Lynchburg, Va.(National Formulary Monograph USP 23/NF18, p.1430).

In one aspect, the phosphate salt laxative includes from 0.05 to 1.5grams per milliliter (g/mL) of monobasic sodium phosphate and from 0.02to 0.6 g/mL of dibasic sodium phosphate. In another aspect, thephosphate salt laxative includes from 0.25 to 1 g/mL or from 0.4 to 1g/mL of monobasic sodium phosphate and from 0.1 to 0.4 g/mL or from 0.13to 0.25 g/mL of dibasic sodium phosphate. At present, an especiallypreferred phosphate salt laxative includes about 0.48 g/mL of monobasicsodium phosphate and about 0.18 g/mL of dibasic sodium phosphate.Phosphate salt laxatives that include one phosphate salt, such asdibasic sodium phosphate, also may be used.

In addition to a water mixture, the phosphate salt laxative may beincorporated into a gel. For example, an aqueous liquid containing thephosphate salts may be combined with a gelling agent to form a gel.Suitable gelling agents may include gelatin, such as Gelatin, Type A, 25Bloom, 50 mesh, from Great Lakes Gelatin, PO Box 917, Grayslake, Ill.;agar such as Sigma brand Agar A-7002 Lot 71K0093; and commerciallyavailable products that include flavorings, such as JELL-O® brand desertmix; and the like. In one aspect, about 85 grams (g) of JELL-O® may beboiled in about 130 mL of water and combined with a near boiling mixturecontaining 45 milliliters (mL) of FLEET® PHOSPHO-SODA® diluted withabout 65 mL of water and the flavorant. Additional details regarding theincorporation of a phosphate salt laxative into a gel may be found inUS. Patent Application Publication No. 2004/0071779 A1.

The phosphate salt laxative may be present in the kit as an aqueousliquid. The term “aqueous liquid” means a liquid containing water and atleast one other ingredient, and includes solutions, suspensions,colloids, dispersions and slurries. The phosphate salt laxative may bepresent in the kit as a solid, including a powdered solid, a granulatedsolid, or one or more tablets. Phosphate salt laxative solids may becombined with water to form an aqueous liquid containing the phosphatesalt laxative. The phosphate salt laxative may be present in the kit inone or more containers, such as bottles, tubs, sachets, envelopes,packets, tubes, ampoules, and the like. The kit may contain thephosphate salt laxative in from 1 to 10 containers, preferably in from 2to 10 containers, more preferably in from 3 to 8 containers, morepreferably in from 4 to 6 containers. Preferably the kit contains atleast two containers of phosphate salt laxative, since colonic cleansingprocedures may involve two separate doses of laxative. More preferablythe phosphate salt laxative is present as an aqueous liquid in two ormore bottles.

The flavorant 120 includes aspartame and a citrate. The citrate mayinclude citric acid; citrate salts, such as sodium or potassium citrate;derivatives of citrate, such as citrate derivatized with esterfunctionality; and the like. Prior to consumption, the flavorant may beadded to the phosphate salt laxative to increase its palatability. Theflavorant also may include natural and/or artificial flavorings, such asnatural and/or artificial fruit flavors, to further increase thepalatability of the laxative. Examples of flavorants that may becombined with phosphate salt laxatives are disclosed, for example, inco-pending U.S. patent application Ser. No. 10/934,638, filed Sep. 3,2004, which is incorporated herein by reference.

The flavorant may be in the form of a commercially availableaspartame-based drink mixture. One such product is CRYSTAL LIGHT® powderavailable from Kraft Foods, Northfield, Ill. CRYSTAL LIGHT® powderincludes aspartame, citric acid, and fruit flavors that result invarious drink flavors when the powder is combined with water. Forexample, lemonade flavored CRYSTAL LIGHT® powder includes citric acid,potassium citrate, aspartame, maltodextrin, magnesium oxide, naturalflavor, acesulfame potassium, lemon juice solids, artificial color,yellow 5 lake, and BHA. At present, CRYSTAL LIGHT® powder may beobtained that will make various drink flavors, including pink lemonade,lemonade, orange, tangerine-strawberry, raspberry-peach, and raspberryice. Other drink flavors, such as raspberry lemonade, raspberry,strawberry-kiwi, strawberry-orange-banana, pineapple-orange, andgrapefruit also may be used as flavorants.

Preferable compositions may include from 15 to 75 mL, from 30 to 60 mL,or from 40 to 50 mL of phosphate salt laxative in combination with from1 to 10 g, from 2 to 6 g, or from 4 to 5 g of CRYSTAL LIGHT® drink mix.The composition also may include from 240 to 480 mL, from 300 to 420 mL,or from 270 to 450 mL of water. At present, an especially preferredcomposition includes about 45 mL of a phosphate salt laxative thatincludes about 0.48 g/mL of monobasic sodium phosphate and about 0.18g/mL of dibasic sodium phosphate, about 4.4 g of CRYSTAL LIGHT® PinkLemonade powder, and about 360 mL of water.

In another aspect, the flavorant may be in the form of a reduced-filleraspartame-based mixture. In relation to a commercially availableaspartame-based drink mixture, such as CRYSTAL LIGHT®, a reduced-filleraspartame-based mixture has a reduced amount of maltodextrin.Preferably, the reduced-filler mixture also contains less naturalflavoring and flowability enhancers than commercially available drinkmixtures. By reducing the amount of maltodextrin, natural flavoring, andthe like, the amount of flavorant added to increase the palatability ofthe phosphate salt laxative may be reduced. A preferable reduced-fillerflavorant includes aspartame, citrates, artificial lemon flavoring, andplant extract. At present, an especially preferred plant extract for usein a reduced-filler flavorant is available from WILD Flavors, Inc.,Erlanger, Ky. and is referred to as RESOLVER®. It is believed that theplant extracts in RESOLVER® occupy the receptors on the tongue that areresponsible for bitter tastes, thus neutralizing the otherwise bitteraspects of the flavorant and/or the phosphate salt laxative.

Preferable compositions may include from 1 to 3 g, preferably about 2 gof a reduced-filler aspartame-based mixture in combination with from 40to 50 mL of a phosphate salt laxative. At present, an especiallypreferred composition includes about 45 mL of a phosphate salt laxativethat includes about 0.48 g/mL of monobasic sodium phosphate and about0.18 g/mL of dibasic sodium phosphate, 2.0 g +/−10% by weight of thereduced-filler aspartame-based mixture, and about 360 mL of water.

The flavorant may be present in a kit as an aqueous liquid. Theflavorant may be present in a kit as a solid, including a powderedsolid, a granulated solid, or one or more tablets. The flavorant may bepresent in the kit in one or more containers, such as bottles, tubs,sachets, envelopes, packets, tubes, ampoules, and the like. Preferablythe kit includes at least two containers of flavorant. More preferablythe kit includes two containers of flavorant, each container having anamount of flavorant appropriate to combine with a single dose ofphosphate salt laxative. Preferably the flavorant is present as a powdercontained in two packets, each packet corresponding to a dose ofphosphate salt laxative.

The kit also may include ascorbic acid or a salt thereof. Due to thepoor stability of ascorbic acid in solution, the ascorbic acid may beseparately packaged and added to the phosphate salt laxative before use.In a preferred aspect, when the flavorant is packaged as a dry powder,the ascorbic acid may be packaged as a dry powder with the flavorant.When packaged as a dry powder, such as with the flavorant, the ascorbicacid may be coated to improve its stability. Suitable coatings includesilicone, ethyl cellulose, and the like. In one aspect, enough ascorbicacid is added to provide a pre-administration solution concentration offrom 0.25 to 50 grams/liter (g/L) or from 1 to 25 g/L. Additionaldetails regarding the use of ascorbic acid in laxative preparations maybe found in U.S. Pat. No. 5,274,001.

The oral rehydration mixture 130 contains sodium and a glucosecontaining saccharide. Sodium may be present in the mixture as a salt.Examples of sodium salts include sodium chloride, sodium phosphate, andsodium citrate. Preferably, the salt has a solubility in water at roomtemperature of at least one gram per liter. The term “glucose containingsaccharide” means either glucose, or a saccharide that can be hydrolyzedto form a composition containing glucose.

Saccharides are polyhydroxy aldehydes or ketones, and includemonosaccharides, disaccharides, oligosaccharides, and polysaccharides.Saccharides typically have a water solubility of at least one gram perliter. Examples of glucose containing saccharides include glucose,sucrose, lactose, maltose, amylose, glycogen and maltodextrin. A varietyof glucose containing saccharides may be present in the oral rehydrationmixture, as may other saccharides that do not contain glucose. Examplesof saccharides that do not contain glucose include fructose, galactose,allose, altrose, mannose, gulose, idose, talose, ribose, arabinose,lyxose, ribose, xylose, erythrose, and threose. As used herein,reference to any saccharide by a single name also includes all forms ofthat saccharide which may be in equilibrium with the specific saccharidenamed, in aqueous mixture at room temperature. For example, the term“glucose” includes glucose and all 5- and 6-membered cyclic hemiacetalsin equilibrium with glucose in aqueous mixture at room temperature.

An oral rehydration mixture may contain other ingredients, such asproteins, amino acids, polylactate, and salts such as potassium,magnesium and calcium salts. An oral rehydration mixture may contain avariety of excipients and/or additives, for example, flavoring agents,coloring agents, carbonates, viscosity modifiers, preservatives, and thelike. Examples of flavoring agents include anise oil, cinnamon oil,vanilla, vanillin, cocoa, chocolate, menthol, grape, peppermint oil, oilof wintergreen, clove oil, bay oil, anise oil, eucalyptus, thyme oil,cedar leaf oil, oil of nutmeg, oil of sage, oil of bitter almonds,cassia oil, citric acid, citrus oils such as lemon, orange, lime andgrapefruit oils, and fruit essences, including apple, pear, peach,berry, wildberry, date, blueberry, kiwi, strawberry, raspberry, cherry,plum, pineapple, and apricot. Examples of coloring agents include FD&CRed No. 3, FD&C Red No. 20, FD&C Yellow No. 6, FD&C Blue No. 2, D&CGreen No. 5, FD&C Orange No. 5, D&C Red No. 8, caramel, ferric oxide,pigments, dyes, tints, titanium dioxide, grape skin extract, beet redpowder, beta carotene, annato, carmine, turmeric, and paprika.

Examples of oral rehydration mixtures and oral rehydration liquidsinclude GATORADE® Thirst Quencher, GATORADE® Endurance Formula,GATORADE® Endurance Series, and PROPEL® Fitness Water (PepsiCo, Inc.;Purchase, N.Y.). Examples of oral rehydration mixtures and oralrehydration liquids include ACCELERADE (PacificHealth Laboratories,Inc.; Matawan, N.J.); ALL SPORT BODY QUENCHER® (Monarch BeverageCompany; Atlanta, Ga.); CYTOMAX sports drink (CytoSport; Benicia,Calif.); GU₂O sports drink (GU Sports; Berkeley, Calif.); and POWERADE®(The Coca-Cola Company; Atlanta, Ga.). Examples of oral rehydrationmixtures and oral rehydration liquids include OralSuero, SueroralHiposódico, and Sueroral Casen (Casen Fleet; Madrid, Spain). Examples oforal rehydration mixtures and oral rehydration liquids includePEDIALYTE® oral rehydration solutions (Ross Products; Columbus, Ohio).

An oral rehydration mixture preferably contains a ratio of glucosecontaining saccharide: sodium of 0.1 to 15 g: 0.1 to 200 millimole(mmol), more preferably 1 to 10 g:2 to 100 mmol, more preferably 5 to 7g:10 to 30 mmol. Preferably the oral rehydration mixture is administeredas an oral rehydration liquid, which is a mixture of the oralrehydration mixture ingredients with water. An oral rehydration liquidpreferably contains from 0.1 to 15% (w/v) of saccharide, more preferablyfrom 1 to 10% (w/v) saccharide, and more preferably from 5 to 7% (w/v)saccharide. Preferably, an oral rehydration liquid contains from 0.1 to200 millimole per liter (mmol/L) of sodium, more preferably from 2 to100 mmol/L sodium, and more preferably from 10 to 30 mmol/L sodium.

The oral rehydration mixture may be present in the kit as an oralrehydration liquid. The oral rehydration mixture may be present in thekit as a solid, including a powdered solid, a granulated solid, or oneor more tablets. The oral rehydration mixture may be present in the kitin one or more containers, such as bottles, tubs, sachets, packets,envelopes, tubes, ampoules, and the like. For example, the kit mayinclude one or more packets containing oral rehydration mixture solids.In another example, the kit may include one or more containers of oralrehydration liquid. The kit may contain two containers of oralrehydration mixture or of oral rehydration liquid, to correspond to twodoses of the phosphate salt laxative.

One or more containers for combining ingredients optionally may bepresent in a kit. A container may be present in the kit in the form of acup, a bottle, a vial, a tube, or the like, which may be formed in partor in whole from plastic, glass, paper, STYROFOAM®, and the like. Acontainer may be equipped with a fully or partially detachable lid thatinitially may be part of the container or may be affixed to thecontainer by mechanical, adhesive, or other means. Preferably the kitcontains one or more cups, and more preferably contains one or moreplastic cups.

One or more anorectal wipes optionally may be present in the kit.Anorectal wipes may be made from any suitable substrate, such as cloth,paper, or combinations thereof, and may be wetted with an aqueousmixture that may include one or more active ingredients. Examples ofactive ingredients include a local anesthetic such as pramoxinehydrochloride, and a protectant such as glycerin. The aqueous mixturealso may include one or more inactive ingredients, such ascetylpyridinium chloride, citric acid, disodium EDTA, eucalyptol,menthol, octoxynol-9, sodium benzoate, and sodium citrate. The anorectalwipes may be in the form of pads and the like, such as FLEET®Pain-Relief Pre-Moistened anorectal pads. In one aspect, fourindividually wrapped wipes are preferred. The anorectal wipes may berectangular in shape, having dimensions of about 4 cm by about 7 cm. Theanorectal wipes may be present in the kit in one or more containers,such as bottles, tubs, sachets, envelopes, packets, tubes, and the like.For example, the kit may include two packets containing one or moreanorectal wipes each. Preferably the kit includes two anorectal wipespackets, each packet containing two anorectal wipes.

Instructions may optionally be present in the kit. Instructions mayinclude directions regarding how to combine the phosphate salt laxativewith the flavorant to form the colonic cleansing composition, regardingwhen to consume the colonic cleansing composition in relation to thetime of a colonoscopy procedure, regarding when to consume the oralrehydration mixture, and how to apply the anorectal wipes to provide thedesired soothing effect. The instructions may be present in a variety offorms, including one or more printed sheets, printing on the outside orinside the exterior package, writing incorporated on one or more of thecontainers enclosed in the exterior package, a CD-ROM, a DVD-ROM, auniform resource locator (URL) for a website, and the like.

The optional exterior package 140 may be sized and configured to containone or more other components of the kit. An exterior package may be acup, a bottle, a vial, a tube, or the like, which may be formed in partor in whole from plastic, glass, paper, STYROFOAM®, and the like. Anexterior package may be equipped with a fully or partially detachablelid that initially may be part of the container or may be affixed to thecontainer by mechanical, adhesive, or other means.

The optional exterior package may include one or more supportingstructures, such as walls, wells, movable or removable trays, etc., soas to segregate the various components. In one example, a kit thatincludes two doses each of phosphate salt laxative, flavorant, and oralrehydration mixture may include an exterior package having a single wallthat partitions the package into two regions, with the componentsintended for use in each dose segregated between the two regions. Inanother example, an exterior package may include walls and/or wells thatallow the individual components to be segregated, such that all thecontainers of phosphate salt laxative are placed together, all thecontainers of flavorant are placed together, and all the containers oforal rehydration mixture are placed together. Supporting structures maybe formed in part or in whole from plastic, glass, paper, STYROFOAM®,and the like. An example of an exterior container that includessupporting structures is disclosed in U.S. Patent ApplicationPublication No. 2005/0061861 A1.

FIG. 2 represents a kit 200 for colonic cleansing including a phosphatesalt laxative 210, a flavorant 220, an oral rehydration mixture 230, anexterior package 240, a container for combining ingredients 250,anorectal wipes 260, and instructions 270. The phosphate salt laxativeand the oral rehydration mixture are each depicted as aqueous liquids,in plastic bottles 212 and 232 having screw-top lids 214 and 234. Theflavorant, in powder form, and the anorectal wipes are depicted asenclosed in packets 222 and 262, respectively, such as packets made fromfoil-lined paper. The exterior package is depicted as a plastic jar 242having a removable screw-type lid 244.

In one example, each laxative bottle may contain about 45 mL ofphosphate salt laxative, and each oral rehydration mixture bottle maycontain about 1.5 to 2 liters of oral rehydration liquid. The flavorantpackets may be rectangular, each packet having a width of about 4.1 toabout 4.4 centimeters (cm) and a length of about 6.3 to about 7.6 cm,and each packet containing about 4 to 5 g flavorant. The anorectal wipepackets may be rectangular, each packet having a width of about 4 toabout 6 cm and a length of about 7 to about 9 cm, and each packetcontaining two wipes.

FIG. 3 represents a kit 300 for colonic cleansing including a phosphatesalt laxative 310, a flavorant 320, an oral rehydration mixture 330, anexterior package 340, a container for combining ingredients 350, andanorectal wipes 360. The phosphate salt laxative is depicted as anaqueous liquid in six plastic bottles 312 having screw-top lids 314. Theflavorant, the oral rehydration mixture (each in powder form) and theanorectal wipes are depicted as enclosed in packets 322, 332 and 362,respectively, such as packets made from foil-lined paper. The exteriorpackage is depicted as a box having instructions 370 printed on the box.

In one example, each bottle contains about 15 mL of phosphate saltlaxative. The flavorant packets, oral rehydration mixture packets, andanorectal wipe packets may be rectangular in shape. The oral rehydrationmixture packet may be rectangular, having a width of about 5 to about 12cm and a length of about 5 to about 12 cm, and containing from 8 to 10 goral rehydration mixture powder. The flavorant packets may berectangular, each packet having a width of about 4.1 to about 4.4centimeters (cm) and a length of about 6.3 to about 7.6 cm, and eachpacket containing about 4 to 5 g flavorant. The anorectal wipe packetsmay be rectangular, each packet having a width of about 4 to about 6 cmand a length of about 7 to about 9 cm, and each packet containing twowipes.

FIG. 4 represents a kit 400 for colonic cleansing including phosphatesalt laxative 410, flavorant 420, oral rehydration mixture 430, anexterior package 440, a container for combining ingredients 450, andanorectal wipes 460. The phosphate salt laxative is depicted as anaqueous liquid in six bottles. The oral rehydration mixture, theflavorant (each in powder form) and the anorectal wipes are depicted asenclosed in packets, such as packets made from foil-lined paper. Theexterior package is depicted as a clam-shell package having a tray 442and a cover 444 pivotally attached to the tray.

FIGS. 5A-5C represent an exterior package 540 similar to exteriorpackage 440 of FIG. 4. The package 540 includes a tray 542, a cover 544pivotally attached to the tray, six wells 541 for bottles of phosphatesalt laxative, a well 543 for one or more containers of oral rehydrationmixture, a well 545 for one or more containers of flavorant andoptionally for one or more containers for combining ingredients, and awell 546 for anorectal wipes. FIG. 5A is a top view representation ofthe open package, FIG. 5B is a side view representation of the openpackage, and FIG. 5C is a front view representation of the closedpackage.

A method for colonic cleansing may include orally administering to asubject a flavored laxative liquid, and orally administering to thesubject an oral rehydration liquid. The flavored laxative liquidcontains a phosphate salt laxative and a flavorant containing aspartameand a citrate. The oral rehydration liquid contains water, sodium and aglucose containing saccharide. By orally administering the flavoredlaxative liquid and the oral rehydration liquid, the colon may becleansed.

Orally administering a flavored laxative liquid may include combiningthe phosphate salt laxative and the flavorant. The phosphate saltlaxative and the flavorant independently may be solid or may be in anaqueous liquid, and the solid(s) and/or liquid(s) may be combined toform the flavored laxative liquid. Water may also be added to thephosphate salt laxative and/or the flavorant, regardless of whether oneor both components are already in the form of an aqueous liquid. In oneexample, an aqueous phosphate salt laxative is combined with a powderedflavorant and water to provide the flavored laxative liquid. In thisexample, the flavorant may include a gelling agent, such that theflavored laxative may be administered in the form of a gel.

Preferably the flavored laxative liquid is administered so that from 0.4to 0.85 g of monobasic sodium phosphate and from 0.1 to 0.5 g of dibasicsodium phosphate are consumed per kilogram of body weight of thesubject. In one example, about 45 mL of a phosphate salt laxative,including about 0.48 g/mL of monobasic sodium phosphate and about 0.18g/mL of dibasic sodium phosphate, is mixed with about 4.4 g of CRYSTALLIGHT® Pink Lemonade powder, and about 360 mL of water. In anotherexample, about 45 mL of a phosphate salt laxative, including about 0.48g/mL of monobasic sodium phosphate and about 0.18 g/mL of dibasic sodiumphosphate, is mixed with about 2.0 g of a reduced-filler aspartame-basedmixture, and about 360 mL of water.

Orally administering to the subject an oral rehydration liquid mayinclude combining an oral rehydration mixture and water, to form theoral rehydration liquid. In one example, from 0.5 to 5 liters of oralrehydration liquid is administered. Preferably the oral rehydrationliquid is orally administered, at least in part after administration ofthe flavored laxative liquid, and before colonic cleansing is complete.However, it is still expected to be effective if administration of theoral rehydration liquid is within a few hours prior to oraladministration of the flavored laxative liquid. Of the fluids orallyadministered from 4 hours before to 24 hours after oral administrationof the flavored laxative liquid, preferably at least 50% of the fluidsare in the form of an oral rehydration liquid. More preferably at least75% of the fluids are in the form of an oral rehydration liquid, andmore preferably at least 90% of the fluids are in the form of an oralrehydration liquid.

A method for colonic cleansing may be carried out in two separate steps.For example, a method for colonic cleansing may include orallyadministering to a subject a first aqueous liquid containing thephosphate salt laxative and the flavorant, orally administering to thesubject a first oral rehydration liquid, orally administering to thesubject a second aqueous liquid containing the phosphate salt laxativeand the flavorant, and orally administering to the subject a second oralrehydration liquid. The compositions of the first and second aqueousliquids may be the same or different, and the compositions of the firstand second oral rehydration liquids may be the same or different.Preferably the administration of the first aqueous liquid and the firstoral rehydration liquid are performed about 14 hours prior to acolonoscopy, and the administration of the second aqueous liquid and thesecond oral rehydration liquid are performed about 3 hours prior to thecolonoscopy.

A method for colonic cleansing using a kit may include combining aphosphate salt laxative with a flavorant to provide a flavored laxativeliquid, orally administering to a subject the flavored laxative liquid,and orally administering to the subject an oral rehydration liquid. Inone example, a method for colonic cleansing using kit 100 includescombining the phosphate salt laxative 110 with the flavorant 120 toprovide a flavored laxative liquid, orally administering to a subjectthe flavored laxative liquid, and orally administering to the subjectthe oral rehydration liquid 130. This method may be carried out in twoseparate steps. For example, orally administering the flavored laxativeliquid may include orally administering a first portion of the flavoredlaxative liquid, and orally administering a second portion of theflavored laxative liquid; and orally administering the oral rehydrationliquid 130 may include orally administering a first portion of the oralrehydration liquid, and orally administering a second portion of theoral rehydration liquid. In this example, the first portion of the oralrehydration liquid is administered prior to the administration of thesecond portion of the flavored laxative liquid.

In another example, a method for colonic cleansing using kit 200includes combining the contents of one phosphate salt laxative bottle212 with the contents of one flavorant packet 220 in the container 250to provide a first flavored laxative liquid, orally administering thefirst flavored laxative liquid, orally administering the contents of oneoral rehydration liquid bottle 232, combining the contents of the otherphosphate salt laxative bottle 212 with the contents of the otherflavorant packet 220 in the container 250 to provide a second flavoredlaxative liquid, orally administering the second flavored laxativeliquid, and orally administering the contents of the other oralrehydration liquid bottle 232. Combining the contents of a phosphatesalt laxative bottle 212 with the contents of a flavorant packet 220 inthe container 250 may include adding additional water to the mixture.

In another example, a method for colonic cleansing using kit 300includes combining the contents of one, two or three phosphate saltlaxative bottles 312 with at least a portion of the contents of oneflavorant packet 320 in the container 350 to provide a first flavoredlaxative liquid; orally administering the first flavored laxativeliquid; combining at least a portion of the contents of one oralrehydration mixture packet 332 with water to provide a first oralrehydration liquid; orally administering the first oral rehydrationliquid; combining the contents of one, two or three of the otherphosphate salt laxative bottles 312 with at least a portion of thecontents of the other flavorant packet 320 in the container 350 toprovide a second flavored laxative liquid; orally administering thesecond flavored laxative liquid; combining at least a portion of thecontents of the other oral rehydration mixture packet 332 with water toprovide a second oral rehydration liquid; and orally administering thesecond oral rehydration liquid.

Combining the contents of one, two or three phosphate salt laxativebottles 312 with at least a portion of the contents of a flavorantpacket 320 in the container 350 may include adding additional water tothe mixture. This method may be used to facilitate the use of variabledoses of the flavored laxative liquid. For example, a subject may beadministered small doses containing one bottle each of the phosphatesalt laxative if the body weight of the subject is below a lowerthreshold value, and a subject may be administered large dosescontaining three bottles each of the phosphate salt laxative if the bodyweight of the subject is above an upper threshold value. An entirepacket of flavorant may be combined with the phosphate salt laxative, ora smaller amount of the flavorant may be used to suit the taste of thesubject. The oral rehydration mixture may be combined with water in thecontainer 350, or it may be combined with water in a differentcontainer.

In another example, a method for colonic cleansing using kit 400includes combining the contents of one, two or three bottles ofphosphate salt laxative 410 with at least a portion of the contents ofone packet of flavorant 420 in the container 450 to provide a firstflavored laxative liquid; orally administering the first flavoredlaxative liquid; combining a portion of the contents of the packet oforal rehydration mixture 430 with water to provide a first oralrehydration liquid; orally administering the first oral rehydrationliquid; combining the contents of one, two or three of the other bottlesof phosphate salt laxative 410 with at least a portion of the contentsof the other packet of flavorant 420 in the container 450 to provide asecond flavored laxative liquid; orally administering the secondflavored laxative liquid; combining at least a portion of the remainingcontents of the packet of oral rehydration mixture 430 with water toprovide a second oral rehydration liquid; and orally administering thesecond oral rehydration liquid. This method may be used to facilitatethe use of variable doses of the flavored laxative liquid.

While various embodiments of the invention have been described, it willbe apparent to those of ordinary skill in the art that other embodimentsand implementations are possible within the scope of the invention.Accordingly, the invention is not to be restricted except in light ofthe attached claims and their equivalents.

1. A kit for colonic cleansing, comprising: a phosphate salt laxative, aflavorant, comprising aspartame and a citrate, and an oral rehydrationmixture, comprising sodium, and a glucose containing saccharide.
 2. Thekit of claim 1, where the phosphate salt laxative comprises at least onesalt selected from the group consisting of monobasic sodium phosphate,dibasic sodium phosphate, and combinations thereof.
 3. The kit of claim1, where the phosphate salt laxative is present as a liquid comprisingwater and from 0.05 to 1.5 gram/mL of monobasic sodium phosphate andfrom 0.02 to 0.6 gram/mL of dibasic sodium phosphate.
 4. The kit ofclaim 3, where the phosphate salt laxative comprises from 0.4 to 1gram/mL of monobasic sodium phosphate and from 0.13 to 0.25 gram/mL ofdibasic sodium phosphate.
 5. The kit of claim 3, where the phosphatesalt laxative comprises 0.48 gram/mL of monobasic sodium phosphate and0.18 gram/mL of dibasic sodium phosphate.
 6. The kit of claim 1, wherethe phosphate salt laxative is present as a solid.
 7. The kit of claim1, where the phosphate salt laxative is present as an aqueous liquid inat least one bottle.
 8. The kit of claim 7, where the phosphate saltlaxative is present as an aqueous liquid in at least two bottles, eachbottle comprising from 10 to 75 mL of the liquid.
 9. The kit of claim 7,where the phosphate salt laxative is present as an aqueous liquid in atleast six bottles, each bottle comprising from 10 to 75 mL of theliquid.
 10. The kit of claim 1, where the flavorant further comprises aflavoring selected from the group consisting of natural fruit flavors,artificial fruit flavors, and combinations thereof.
 11. The kit of claim1, where the citrate comprises citric acid and potassium citrate; andthe flavorant further comprises maltodextrin, natural flavor, acesulfamepotassium, lemon juice solids, and artificial color.
 12. The kit ofclaim 1, where the flavorant further comprises ascorbic acid or a saltthereof.
 13. The kit of claim 1, where the flavorant is present as anaqueous liquid. 14-29. (canceled)
 30. A kit for colonic cleansing,comprising: at least two bottles, each comprising from 10 to 75 mL aphosphate salt laxative, the phosphate salt laxative comprising water,from 0.05 to 1.5 gram/mL of monobasic sodium phosphate, and from 0.02 to0.6 gram/mL of dibasic sodium phosphate at least two packets, eachcomprising from 1 to 10 grams of a powdered flavorant, the flavorantcomprising aspartame and a citrate, and at least one packet comprisingfrom 200 to 400 grams of a powdered oral rehydration mixture, the oralrehydration mixture comprising sodium, and a glucose containingsaccharide.
 31. The kit of claim 30, further comprising a containercomprising an internal volume of from 50 to 500 mL. 32-41. (canceled)42. The kit of claim 30, comprising six bottles, each comprising from 10to 75 mL of the phosphate salt laxative.
 43. (canceled)
 44. A method forcolonic cleansing, comprising: combining a phosphate salt laxative and aflavorant to provide a flavored laxative liquid, the flavorantcomprising aspartame and a citrate; orally administering to a subjectthe flavored laxative liquid; and orally administering to the subject anoral rehydration liquid, the oral rehydration liquid comprising sodiumand a glucose containing saccharide. 45-50. (canceled)
 51. A method forcolonic cleansing using the kit of claim 30, comprising: combining thecontents of at least one of the bottles of the phosphate salt laxativewith at least one of the packets of the flavorant, to provide a firstflavored laxative liquid; orally administering the first flavoredlaxative liquid; combining a portion of the oral rehydration mixturewith water to provide a first oral rehydration liquid; orallyadministering the first oral rehydration liquid; combining the contentsof at least one of the bottles of the phosphate salt laxative with atleast one of the packets of the flavorant, to provide a second flavoredlaxative liquid; orally administering the second flavored laxativeliquid; combining a portion of the oral rehydration mixture with waterto provide a second oral rehydration liquid; and orally administeringthe second oral rehydration liquid.
 52. A method for colonic cleansingusing the kit of claim 31, comprising: combining the contents of atleast one of the bottles of the phosphate salt laxative with at leastone of the packets of the flavorant in the container, to provide a firstflavored laxative liquid; orally administering the first flavoredlaxative liquid; combining a portion of the oral rehydration mixturewith water to provide a first oral rehydration liquid; orallyadministering the first oral rehydration liquid; combining the contentsof at least one of the bottles of the phosphate salt laxative with atleast one of the packets of the flavorant in the container, to provide asecond flavored laxative liquid; orally administering the secondflavored laxative liquid; combining a portion of the oral rehydrationmixture with water to provide a second oral rehydration liquid; andorally administering the second oral rehydration liquid.
 53. A methodfor colonic cleansing using the kit of claim 42, comprising: combiningthe contents of from 1 to 3 of the bottles of the phosphate saltlaxative with at least one of the packets of the flavorant, to provide afirst flavored laxative liquid; orally administering the first flavoredlaxative liquid; combining a portion of the oral rehydration mixturewith water to provide a first oral rehydration liquid; orallyadministering the first oral rehydration liquid; combining the contentsof from 1 to 3 of the bottles of the phosphate salt laxative with atleast one of the packets of the flavorant, to provide a second flavoredlaxative liquid; orally administering the second flavored laxativeliquid; combining a portion of the oral rehydration mixture with waterto provide a second oral rehydration liquid; and orally administeringthe second oral rehydration liquid.